National Cohort Study on Infant Gut Microbiota and Nutrition
Study on Gut Microbiota Characteristics and Their Relationship With Nutritional Health in Infants and Young Children Based on a National Cohort
調査の概要
状態
詳細な説明
The human gastrointestinal tract harbors vast and diverse microbial communities collectively termed the "gut microbiota", widely known as the human body's "second genome". Research has demonstrated that during the colonization and maturation of gut microbiota in early infancy, these microbes participate in multiple core physiological processes including immune system maturation, nutrient absorption and metabolism, and nervous system development. Infancy represents a critical window for the establishment of intestinal microecology. Disturbances from adverse environmental factors such as antibiotic administration, inappropriate dietary patterns, and environmental pollution may trigger dysbiosis of microbial composition, which in turn elevates the long-term risk of developing obesity, allergic disorders, asthma, autism spectrum disorders and other diseases.
The formation and dynamic shifts of childhood gut microbiota are shaped not only by early-life exposures including mode of delivery, breastfeeding status and antibiotic use, but also by subsequent dietary patterns, living environments and socioeconomic status. For instance, high-fat diets reduce the abundance of beneficial gut bacteria, whereas Mediterranean-style diets support intestinal health; antibiotic treatment markedly diminishes microbial diversity and impairs community stability; urban-rural disparities also drive profound differences in gut microbial composition.
To date, domestic research on gut microbiota among infants and children has largely consisted of regional, small-cohort studies, lacking large-scale baseline datasets covering diverse geographic regions, age brackets and health statuses across China. This gap partially hinders the accumulation of scientific evidence for pediatric intestinal health research and disease prevention and control, and restricts the formulation of localized nutritional intervention strategies.
Accordingly, this study aims to conduct a large-cohort investigation covering infants and children aged 0 to 6 years nationwide. Through metagenomic sequencing and microbial isolation and culture of fecal specimens, we will construct gut microbiota atlases stratified by age, geographic region and health profile. The research will focus on associations between representative core gut taxa (e.g., Bifidobacterium) and indicators including children's nutritional status, immune development, allergic manifestations, gastrointestinal function and physical growth. We will also characterize microbial succession patterns during critical developmental windows in early life. Multivariate modeling and machine learning algorithms will be applied to screen microbial biomarkers strongly correlated with specific health conditions, and further dissect their underlying biological mechanisms.
This project is led by a professional research team with extensive experience in intestinal microecology. The team has previously completed gut microbiota profiling and analysis for thousands of infant subjects, obtained ethical approval and secured third-party laboratory qualification, laying a solid research foundation. Findings from this study will provide data support for early identification and intervention of common childhood illnesses, and deliver vital scientific evidence for developing personalized nutritional and health management strategies tailored to gut microecological signatures in Chinese children.
研究の種類
入学 (推定)
連絡先と場所
研究場所
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Shanghai、中国
- DiPROBIO(Shanghai) Co., Ltd.
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参加基準
適格基準
就学可能な年齢
- 子
健康ボランティアの受け入れ
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- Infants and children aged 0-6 years, regardless of gender.
- Volunteers willing to participate in fecal sample collection and baseline health information gathering during the study period.
- Legal guardians must agree to participate in the study and provide a signed written informed consent.
Exclusion Criteria:
- Presence of congenital developmental anomalies, including but not limited to congenital cardiovascular malformations and chromosomal aneuploidy.
- Immune system functional disorders, such as Severe Combined Immunodeficiency.
- Diagnosis of hereditary diseases, such as genetic disorders caused by chromosomal abnormalities.
- Any condition deemed unsuitable for participation by the investigator, including but not limited to failure to meet compliance assessment standards.
研究計画
研究はどのように設計されていますか?
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
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National cohort of Chinese children aged 0-6 years
This single nationwide cohort enrolls a total of 106,667 Chinese infants and children under 6 years old.
enrollment.
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This study is purely observational with no therapeutic or invasive clinical interventions implemented.
We only collect non-invasive fecal specimens from enrolled healthy infants and children aged 0-6 years across China, perform microbial genome sequencing and microbial isolation culture to analyze gut microbiota characteristics, and construct a national pediatric gut microbiome atlas.
No drugs, medical devices or clinical treatment adjustments are given to participants throughout the research.
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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
時間枠 |
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Establish a national gut microbiome atlas of infants and children aged 0-6 years covering all 34 provincial-level administrative regions in China, incorporating subjects across distinct age brackets and geographic backgrounds
時間枠:Baseline (single time point at enrollment)
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Baseline (single time point at enrollment)
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協力者と研究者
捜査官
- 主任研究者:Qinghua Yu、DiproBio (Shanghai) Co., Ltd.
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- SECCR2025-158-01
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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